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The new revision to the annex includes a number of revised requirements. What steps are being taken by EU authorities to assure the consistent interpretation of the requirements of the revised annex by EU GMP inspectors during inspections?

19/09/2021 | 699

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Reply:

GMP inspectors the EU have worked together with inspectors Swissmedic to prepare harmonised guidance on the interpretation of the revised annex to be used during the inspection of manufacturers by their Inspectors. This document has subsequently been proposed and adopted as draft guidance by the Pharmaceutical Inspection Cooperation Scheme (PIC/S): GMP annex 1 revision 2008:Interpretationofmostimportantchangesforthemanufactureofsterilemedicinalproducts .

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